NDC 68094-101

PHENTOLAMINE MESYLATE

Phentolamine Mesylate

PHENTOLAMINE MESYLATE is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Precision Dose Inc.. The primary component is Phentolamine Mesylate.

• Product ID: 68094-101_19113972-a860-47ab-ab3f-e58e404117f9
• NDC: 68094-101
• Product Type: Human Prescription Drug
• Proprietary Name: PHENTOLAMINE MESYLATE
• Generic Name: Phentolamine Mesylate
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2017-07-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207686
• Labeler Name: Precision Dose Inc.
• Substance Name: PHENTOLAMINE MESYLATE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68094-101-10

10 CARTON in 1 TRAY (68094-101-10) > 1 VIAL in 1 CARTON (68094-101-20) > 1 INJECTION in 1 VIAL

• Marketing Start Date: 2017-07-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68094-101-10 [68094010110]

PHENTOLAMINE MESYLATE INJECTION

• Marketing Category: ANDA
• Application Number: ANDA207686
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-15

NDC 68094-101-20 [68094010120]

PHENTOLAMINE MESYLATE INJECTION

• Marketing Category: ANDA
• Application Number: ANDA207686
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-15

Drug Details

Active Ingredients

Ingredient	Strength
PHENTOLAMINE MESYLATE	5 mg/1

OpenFDA Data

• SPL SET ID: e146c7ee-d2fa-433c-8768-0945e4ff0990
• Manufacturer:
  • Precision Dose Inc.
• UNII:
  • Y7543E5K9T
• RxNorm Concept Unique ID - RxCUI:
  • 1361023
• UPC Code:
  • 0368094101202

Pharmacological Class

• Adrenergic alpha-Antagonists [MoA]
• alpha-Adrenergic Blocker [EPC]

NDC Crossover Matching brand name "PHENTOLAMINE MESYLATE" or generic name "Phentolamine Mesylate"

NDC	Brand Name	Generic Name
0143-9564	Phentolamine Mesylate	Phentolamine Mesylate
51224-012	Phentolamine Mesylate	Phentolamine Mesylate
68094-101	PHENTOLAMINE MESYLATE	PHENTOLAMINE MESYLATE
0362-0101	Oraverse	Phentolamine Mesylate